Multi Center Observation of Sentinel Skin Graft for Detecting Acute Rejection After Renal Transplantation

Recruiting

• Conditions: Skin Graft; Kidney Transplant Rejection
• Interventions: Procedure: Skin allotransplantation

• Registration Number: NCT05600634
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

The purpose of this study was to explore the accuracy of sentinel skin grafts from the same donor source in diagnosing renal allograft rejection, and to provide new ideas and options for the later clinical diagnosis of renal allograft rejection. Further, try to provide timing guidance for early immunization intervention.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-27
• Study First Submitted QC: 2022-10-27
• Study First Posted: 2022-10-31
• Status Verified: 2023-10
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-28
• Study Start: 2024-01-01
• Primary Completion: 2026-06-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Patients with end-stage renal disease undergoing renal transplantation;
2. 18-60 years old;
3. Postoperative follow-up points are complete (visit the hospital every week in the first month after surgery, every two weeks in 2-3 months, every four to six months, and every three months in 7-12 months. Follow up at any time when skin rejection is observed. The follow-up time may be adjusted when the condition changes);
4. The participants had good compliance, volunteered to participate in the test and signed the informed consent form.

Exclusion Criteria

1. Untreated or disseminated malignant tumor;
2. Active period of infectious diseases;
3. Serious cardiovascular disease occurred recently;
4. Combined with other important organ failure;
5. History of mental illness or cognitive impairment;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Kidney and skin transplataiton	Skin allotransplantation	-

Primary Outcome Measures

Name	Time	Method
2017 Banff Kidney Transplantation Rejection Rating	Through study completion, an average of 1 year	A rating evaluation on kidney rejection
2007-edition Banff skin containing allogeneic composite histopathological diagnosis grading	Through study completion, an average of 1 year	Skin histopathological diagnosis
Renal function testing	Through study completion, an average of 1 year	Blood Cr and Bun testing

Secondary Outcome Measures

Name	Time	Method
Complications	Through study completion, an average of 1 year	Complications assessment
Renal ultrasound diagnosis	Through study completion, an average of 1 year	Renal ultrasound diagnosis

Trial Locations

Locations (3)

Xijing Hospital, Ari Force Medical University; 🇨🇳 Xi'an, Shannxi, China

First Affiliated Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China